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FDA 510(k)

LEGION System

K-Number: K191650 · 2019-11-01

ApplicantAlcon Research, LLC
Decision Date2019-11-01
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LEGION System is a medical device manufactured by Alcon Research, LLC. It received FDA 510(k) clearance on 2019-11-01 under approval number K191650. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEGION System?

LEGION System is a medical device that received FDA 510(k) clearance on 2019-11-01. It is manufactured by Alcon Research, LLC. The 510(k) number is K191650.

When was LEGION System approved by the FDA?

LEGION System received FDA 510(k) clearance on 2019-11-01, under approval number K191650.

What company makes LEGION System?

LEGION System is manufactured by Alcon Research, LLC.

What is the FDA product code for LEGION System?

The FDA product code for LEGION System is HQC.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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